Redundant Identification for Sample Tracking on a Diagnostic Device

ABSTRACT

A sample-containing device configured to be placed into a sample processing instrument for performing a process on a sample contained in the device includes redundant identification features, such as machine-readable tags. A first machine-readable information tag is read before the device is placed in the instrument, and a second machine-readable information tag is read after the device is in the instrument. Information read from the two tags is compared to determine if there is proper correspondence between the information read from the tags to ensure that the correct sample processing device was placed in the instrument.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit under 35 U.S.C. § 120 of the filingdate of non-provisional patent application U.S. Ser. No. 14/538,602filed Nov. 11, 2014, the disclosure(s) which is (are) incorporatedherein by reference.

FIELD OF THE DISCLOSURE

This disclosure describes methods, systems, and apparatus for providingredundant identification of a sample device to ensure accurateidentification of the sample contained in the sample device.

BACKGROUND

Instruments or systems for performing diagnostic tests or otherprocesses on patient samples, such as molecular diagnostic tests,commonly employ barcode technology to encode a patient or sample ID(also called an accession ID) to track a sample throughout a laboratoryfacility. A barcode is placed on a device associated with the sample,such, as a test tube, cuvette, bottle or other container, a slide, amulti-chamber integrated test cartridge, or other device. In some casesthe device is disposable and is discarded after the test procedure iscomplete and the results are recorded. The barcode is manually scannedor is read by a fixed scanner on the instrument before or after thedevice is placed into the instrument, thereby providing an associationbetween the information encoded in the barcode and the contents of thedevice. For obvious reasons, it is critical that the association betweenthe information encoded in the barcode and the contents of the device beaccurate. That is, if the device contains a patient sample, it iscritical that the information encoded in the barcode on that deviceidentify the correct patient.

When a barcode, or other scanable ID tag, is scanned outside aninstrument before placing the device in the instrument, the associationbetween the contents of the device and the information encoded in abarcode is created outside the instrument, and that association mayapply throughout the processing operation. For example, when aninstrument has a number of distinct processing locations in which adevice may be placed for processing, the user may select an availableprocessing location or the instrument may instruct the user whichprocessing location to use next. In this case, the association betweenthe ID information and the device contents for a particular processinglocation is created before the device is placed in that processinglocation. For example, if the use selects or is instructed to next loadprocessing location “six” and then scan an ID for “patient B”, theinstrument will be expecting patient B's sample in processing locationsix, and the results of the test that is performed in processinglocation six will be associated with patient B. Thus, a problem iscreated if, after creating the association between processing locationsix and patient B, a device containing another patient's sample,“patient C,” is placed in processing location six.

Often when a diagnostic instrument is being prepared for operation bylaboratory personnel, there are multiple sample devices that must beloaded into the instrument, each device with its own unique accession IDor barcode. If the laboratory personnel scans the ID code of a firstdevice, i.e., “device A,” and then mistakenly loads a different device,i.e., “device B,” into the instrument, the instrument will incorrectlyassociate the results of tests performed on patient B's sample topatient A.

SUMMARY

This disclosure describes methods, systems, and apparatus for providingredundant identification of the sample device—both inside and outside aninstrument—to ensure accurate identification of the sample contained inthe sample device.

According to one aspect of the disclosure a sample processing cartridgecomprises a substrate configured to be inserted into a sample processinginstrument, a sample compartment supported on the substrate andconfigured to contain a sample material, and one or more processcompartments supported on the substrate and configured to contain aprocess material. The sample compartment is connected or connectable toat least one process compartment. The cartridge includes firstmachine-readable information tag mounted on or embedded in thesubstrate, encoded with cartridge-identifying information, andconfigured to be read by a device that is external to a sampleprocessing instalment. The cartridge also includes a secondmachine-readable information tag mounted on or embedded in thesubstrate, encoded with cartridge-identifying information correspondingto the cartridge-identifying information encoded in the firstmachine-readable information tag, and configured to be read by a devicewithin a sample processing instrument.

According to another aspect of the disclosure, the firstmachine-readable information tag comprises an optically-readable tag.

According to another aspect of the disclosure, the firstmachine-readable information tag comprises a bar code.

According to another aspect of the disclosure, the first machinereadable information tag comprises a 1-D or a 2-D bar code.

According to another aspect of the disclosure, the secondmachine-readable information tag comprises an electronically-readabletag.

According to another aspect of the disclosure, the secondmachine-readable information tag comprises a wirelessly-readable tag.

According to another aspect of the disclosure, the secondmachine-readable information tag comprises an RFID tag or an EEPROM tag.

According to another aspect of the disclosure, the cartridge-identifyinginformation encoded in the second machine-readable information tagcomprises information that is identical to the cartridge-identifyinginformation encoded in the first machine-readable information tag.

According to another aspect of the disclosure, the cartridge-identifyinginformation comprises an identification code comprised of a uniquecombination of numeric and/or alphabetic characters.

According to another aspect of the disclosure, the cartridge furthercomprises a machine-readable sample identification tag encoded withsample-identifying information and configured to be read by a devicethat is external to a sample processing instrument.

Another aspect of the disclosure is embodied in a system for processinga sample. The system comprises a sample processing cartridge, whichcomprises a substrate, a sample compartment supported on the substrateand configured to contain a sample material, one or more processcompartments supported on the substrate and configured to contain aprocess material. The sample compartment is connected or connectable toat least one process compartment. The cartridge further includes a firstmachine-readable information tag mounted on or embedded in the substrateand encoded with cartridge-identifying information and configured to beread by a device that is external to a sample processing instrument anda second machine-readable information tag mounted on or embedded in thesubstrate and encoded with cartridge-identifying informationcorresponding to the cartridge-identifying information encoded in thefirst machine-readable information tag. The system further includes afirst tag reading device configured to read the first machine-readableinformation tag and to read a machine-readable sample identification tagplaced on the cartridge and a first data processor element configured toassociate information read from the first machine-readable informationtag by the first tag reading device with information read from themachine-readable sample identification tag by the first tag readingdevice. The system further includes a processing instrument configuredto receive the sample processing cartridge, a second tag reading deviceoperatively-associated with the processing instrument and configured toread the second machine-readable information tag when a sampleprocessing cartridge is placed in the processing instrument, and asecond data processor element configured to compare the information readfrom the second machine-readable information tag by the second tagreading device with information read from the first machine-readableinformation tag by the first tag reading device to ensure thecartridge-identifying information contained in the firstmachine-readable information tag corresponds to thecartridge-identifying information contained in the secondmachine-readable information tag.

According to another aspect of the disclosure, the second dataprocessing element, is further configured to enable operation of theprocessing instrument if the cartridge-identifying information containedin the first machine-readable information tag corresponds to thecartridge-identifying information contained in the secondmachine-readable information tag or disable operation of the processinginstrument if the cartridge-identifying information contained in thefirst machine-readable information tag does not correspond to thecartridge-identifying information contained in the secondmachine-readable information tag.

According to another aspect of the disclosure, the firstmachine-readable information tag comprises an optically-readable tag,and the first tag reading device comprises an optical tag scanner.

According to another aspect of the disclosure, the firstmachine-readable information tag comprises a bar code, and the first tagreading device comprises a hand-held bar-code scanner.

According to another aspect of the disclosure, the first machinereadable information tag comprises a 1-D or a 2-D bar code.

According to another aspect of the disclosure, the secondmachine-readable information tag comprises an electronically-readabletag, and the second tag reading device comprises an electronic tagreading device.

According to another aspect of the disclosure, the secondmachine-readable information tag comprises a wirelessly-readable tag,and the second tag reading device comprises a wireless tag scanner.

According to another aspect of the disclosure, the secondmachine-readable information tag comprises an RFID tag or an EEPROM tag.

According to another aspect of the disclosure, the cartridge-identifyinginformation encoded in the second machine-readable information tagcomprises information that is identical to the cartridge-identifyinginformation encoded in the first machine-readable information tag.

According to another aspect of the disclosure, the cartridge-identifyinginformation comprises an identification code comprised of a uniquecombination of numeric and/or alphabetic characters

Other features and characteristics of the subject matter of thisdisclosure, as well as the methods of operation, functions of relatedelements of structure and the combination of parts, and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding pans in thevarious figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a sample processing cartridge includingredundant cartridge identification features.

FIG. 2 is a top plan view of the cartridge.

FIG. 3 is an instrument suitable for processing the cartridge.

FIG. 4 is a schematic view of a data processing system for processingredundant identification data associated with the sample processingcartridge.

FIG. 5 is a flow chart illustrating a redundant identification processusing the sample cartridge.

DETAILED DESCRIPTION

While aspects of the subject matter of the present disclosure may beembodied in a variety of forms, the following description andaccompanying drawings are merely intended to disclose some of theseforms as specific examples of the subject matter. Accordingly, thesubject matter of this disclosure is not intended to be limited to theforms or embodiments so described and illustrated.

Unless defined otherwise, all terms of art, notations and othertechnical terms or terminology used herein have the same meaning as iscommonly understood by one of ordinary skill in the art to which thisdisclosure belongs. All patents, applications, published applicationsand other publications referred to herein are incorporated by referencein their entirety. If a definition set forth in this section is contraryto or otherwise inconsistent with a definition set forth in the patents,applications, published applications, and other publications that areherein incorporated by reference, the definition set forth in thissection prevails over the definition that is incorporated herein byreference.

Unless otherwise indicated or the context suggests otherwise, as usedherein, “a” or “an” means “at least one” or “one or more.”

This description may use relative spatial and/or orientation terms indescribing the position and/or orientation of a component, apparatus,location, feature, or a portion thereof. Unless specifically stated, orotherwise dictated by the context of the description, such terms,including, without limitation, top, bottom, above, below, under, on topof, upper, lower, left of, right of, in front of, behind, next to,adjacent, between, horizontal, vertical, diagonal, longitudinal,transverse, radial, axial, etc., are used for convenience in referringto an absolute or relative position and/or orientation of suchcomponent, apparatus, location, feature, or a portion thereof in thedrawings and are not intended to be limiting.

Furthermore, unless otherwise staled, any specific dimensions mentionedin this description are merely representative of an exemplaryimplementation of a device embodying aspects of the disclosure and arenot intended to be limiting.

A sample processing cartridge having redundant data features asdisclosed herein is shown in FIGS. 1 and 2. The sample processingcartridge 10 includes a substrate 12 on which at least one samplecompartment 14 and one or more process compartments 16 a-16 f aresupported. The substrate may comprise any suitable structure, such as apanel, a shroud, a housing, or some combination thereof for supportingor mounting thereon or therein the sample compartment 14 and the one ormore process compartments 16 a-16 f. In various embodiments, thesubstrate 12 is made of a lightweight, inexpensive material suitable forhigh-volume manufacturing, such as plastic.

The sample compartment 14 may comprise a well mounted on or formedwithin the substrate 12 and may further include a cap configured to beengaged with the well to selectively open or close the well. The samplecompartments 16 a-16 f may comprise chambers or vessels suitable forcontaining therein a process material, or suitable for receiving aprocess material, that may be used in connection with an assay or othertest procedure performed on a sample material with the cartridge.Exemplary process materials include reagents, buffers, oil, particlesfor immobilizing thereon analytes of interest within the sample, such asmagnetic particles, etc. One or more of the process compartments 16 a-16f may be initially empty and may be configured to receive a processmaterial, a mixture of process materials from one or more of the othercompartments, and/or a mixture of process material(s) and samplematerial, or the process compartment may be configured to receive wastematerial generated during a sample processing operation. The samplecompartment 14 may be connected directly or indirectly to one or more ofthe process compartments 16 a-16 f and/or to inlet or outlet ports bychannels or conduits which may be formed in the substrate 12. Inaddition, one or more of the process compartments 16 a-16 f may beconnected directly or indirectly to each other and/or to inlet or outletports by channels or conduits formed in the substrate 12.

The process compartments 16 a-16 f may comprise deformable pouches orblisters configured to be collapsed upon application of an externallyapplied force to expel the contents of the compartment out of thecompartment and into a conduit or other location within the cartridge10. Alternatively, or in addition, the cartridge 10 may be configured tobe coupled to an external source of positive or negative pressure forgenerating material motive forces for moving fluids or other materialsinto and/or out of the various compartments of the cartridge 10.

The sample processing cartridge 10 includes redundant identificationfeatures so that the cartridge may be first automatically identifiedusing a first of the redundant identification features before thecartridge is placed into a processing instrument and then identified asecond time using a second of the redundant identification features(i.e., a confirmatory identification) after the cartridge is placed intoa processing instrument. Correspondence between the first and secondidentifications helps ensure that the cartridge identified outside ofthe processing instrument is the same cartridge later identified insidethe processing instrument.

A first of the redundant identification features comprises a firstmachine-readable information tag 18. In the illustrated embodiment, thefirst machine-readable information tag 18 comprises anoptically-readable tag, such as a one-dimensional barcode or atwo-dimensional barcode (as shown) mounted on an external surface of thesubstrate 12. In an alternative embodiment, the first machine-readableinformation tag may comprise an electronically-readable tag and maycomprise a device configured for wireless (or contactless) scanning,such as an RFID tag embedded within the substrate 12 and readable usinga RFID tag reader or an electronically erasable programmable read-onlymemory module (EEPROM) mounted on or embedded within the substrate 12.

The first machine-readable information tag 18 may be encoded withcartridge-identifying information, which may comprise numeric and/oralphanumeric symbols, such as a serial number uniquely associated withthat particular cartridge, and which can be accessed by a suitable tagreading device, such as a barcode reader, an RFID reader, or an EEPROMreader.

The second of the redundant identification features comprises a secondmachine-readable information tag 20. In the illustrated embodiment, thesecond machine-readable information tag is indicated by a dashedrectangle in FIG 2 indicating a machine-readable tag that is embedded inthe substrate 12. In various embodiments, the second machine-readableinformation tag comprises an electronically-readable tag or chip, suchas an RFID chip or an EEPROM chip, embedded within the substrate 12. Inother embodiments, the second machine-readable information tag 20 maycomprise an optically-readable tag mounted on an exterior surface of thesubstrate 12, such as a one-dimensional or two-dimensional barcode.

The second machine readable information tag is encoded with informationidentifying the cartridge 10. In one embodiment, a serial numberuniquely associated with the cartridge 10 may be encoded in the secondmachine-readable information tag 20, and that serial number will beaccessible by an appropriate reading device such as an RFID reader, anEEPROM reader, or a barcode reader (scanner).

To provide the redundant identification, the cartridge identifyinginformation encoded into the first machine-readable information tagpreferably corresponds to the cartridge identifying information encodedinto the second machine-readable information tag. The correspondencebetween the cartridge identifying information encoded into the firstmachine-readable information tag and the cartridge identifyinginformation encoded into the second machine-readable information tagcreates a one-to-one association between the cartridge identifyinginformation in each tag. In one embodiment, the correspondence betweenthe cartridge identifying information encoded into the first and secondmachine-readable information tags is provided by using identicalcartridge identifying information in each tag, such as an identicalserial number uniquely associated with the cartridge 10. In analternative embodiment, the cartridge identifying information encoded ineach of the first and second machine readable information tags is notidentical, but correspondence between the information encoded in thetags is manufactured by creating an association between the differentcartridge identifying information, for example, in a relationaldatabase. Thus, proper correspondence between the cartridge identifyinginformation scanned from the first and second machine-readableinformation tags confirms that the tags are associated with the samecartridge.

The cartridge 10 may further include a machine-readable sampleidentification tag 22 placed on the cartridge, for example on anexterior surface of the substrate 12. In one embodiment, themachine-readable sample identification tag 22 is an optically readablesymbol, such a one-dimensional barcode (as shown) or a two-dimensionalbarcode. In other embodiments, the machine-readable sampleidentification tag is an electronically readable tag, such as an RFIDchip or an EEPROM chip, embedded within the substrate 12.

The machine-readable sample identification tag is encoded withinformation identifying the nature and/or source of the sample materialthat is to be processed in the sample processing cartridge 10.Alternatively, the machine-readable sample identification tag is encodedwith information that enables a table lookup of information identifyingthe nature and/or source of the sample material that is to be processed.In an embodiment, the machine-readable sample identification tag isencoded with information identifying a patient from whom the sample tobe processed was obtained or is encoded with information thatfacilitates a database retrieval of information identifying the patient.Other information that may be encoded in the sample identificationtag—or retrievable based on information encoded in the sampleidentification tag—may include the date on which the sample was acquiredand the test(s) that is (are) to be performed on the sample. In variousembodiments, the machine-readable sample identification tag may beencoded with a patient accession number uniquely associated with thepatient or some other number that is associated with the patientaccession number.

In one embodiment, the first machine-readable information tag 18 isconfigured to be read by a tag reading device located outside of theprocessing instrument in which the sample processing cartridge 10 is tobe processed. As noted, the first machine-readable information tag 18may comprise an optically readable tag, such as a one-dimensional ortwo-dimensional barcode, that can be read by a barcode scanner locatedoutside of the processing instrument.

The second machine-readable information tag is configured to be read bya tag reading device inside the processing instrument in which thesample processing cartridge 10 will be processed. In an embodiment, thesecond machine-readable information tag 20 is an electronically readabletag such as an RFID tag or and EEPROM chip.

In certain embodiments, it may be preferable that the first and secondmachine-readable information tags are different types of tags so that adevice used for reading one of the tags cannot also be used to read theother tag. For example, it may be preferable that the firstmachine-readable information tag is an optically readable tag, such as abarcode, that can be read outside of the processing instrument using afixed or hand-held barcode scanner or reader and that the second machinereadable information tag is not an optically readable tag, so that thesecond machine-readable information tag is not mistakenly read outsideof the processing instrument instead of or in addition to reading thefirst machine-readable information tag. Thus, for example, the secondmachine-readable information tag may comprise an electronically readabletag such as an RFID tag or an EEPROM chip that cannot be read by abarcode scanner intended to scan the optically readable firstmachine-readable information tag.

An exemplary instrument configured for processing the sample processcartridge 10 is indicated by reference number 30 in FIG. 3. Theinstrument 10 comprises a control console or base 32 having an interfacescreen 34, one or more processing modules 36 operatively coupled to thecontrol console 32, processing bays 40 a, 40 b, 40 c, 40 d, 40 e, 40 fwithin each processing module 36, each of which is configured to receivea sample process cartridge 10 and process the cartridge 10 independentlyof the other bays, and instrument software (ISW). In variousembodiments, the instrument comprises one control console 32 and one ormore processing modules 36, with each processing module including sixprocessing bays 40 a-40 f. Each processing module 36 is operativelycoupled to the control console 32. e.g., to exchange power, input andoutput data, and control signal transmissions with the control console32 and may be physically connected to the control console 32 as well.The processing module(s) 34 may be an integral part of or releasablyattached to the control console 32. Each processing bay 40 a-40 f withinthe processing module 36 is configured to accept one sample processcartridge 10 at a time and to process the cartridge independently ofother processing bays processing other cartridges.

The ISW provides the graphical user interface via the interface screen34 for the user to start runs, receive results, and provide inputs thatat least partially control operation of the instrument 30. In variousembodiments, the ISW is configured to run on a Windows® computer, andinterface screen 34 comprises a touchscreen providing the primaryfunctionality for user input. In various embodiments, the instrument 32is configured to provide connectivity to a local area network (“LAN”)and a laboratory information system (“LIS”).

Each processing bay 40 a-40 f includes hardware, firmware, andelectronics for performing a process, e.g., a molecular diagnosticassay, on a sample process cartridge 10. Each processing bay 40 a-40 fmay include the electronics and firmware of the processing bay (such as,microprocessors and firmware on the microprocessors), circuitry thatsupplies power, circuitry that performs sensing of reaction products onthe process cartridge, circuitry that controls heaters in the processingbay that interact with the process cartridge, circuitry that measuresand controls temperatures in the process cartridge, circuitry thatcontrols motion of various moving components of the processing bay, andcircuitry that controls a pump of the processing bay.

Instrument 30 may further include a first tag reading device that isconfigured to read the first machine-readable information tag 18 on thecartridge 10 before the cartridge is placed into the processinginstrument—e.g., into one of the processing bays 40 a-40 f. The firsttag reading device may further be configured to read a machine-readablesample identification tag 22 placed on the cartridge 10. The tag readingdevice may comprise an optical tag scanner. In the illustratedembodiment, the first tag reading device comprises a handheld barcodereader 42 and/or a fixed barcode reader or scanner bay 44 positionedwithin the instrument 30, for example within the base 32. The handheldbarcode reader 42 can be used to read the two-dimensional barcode of thefirst machine-readable information tag 18 as well as the one-dimensionalbarcode of the machine-readable sample identification tag 22 before thecartridge is inserted into one of the processing base 40 a-40 f of theprocessing instrument 30. Alternatively, the barcode scanner can beprovided within a scanner bay 44 into which the cartridge may beinserted to scan barcodes 18 and 22 before removing the cartridge 10from the scanner bay 44 and inserting the cartridge 10 into one of theprocessing bays 40 a-40 f.

A data processing system for processing redundant identification dataassociated with the cartridge 10 is schematically shown in FIG. 4.Various components of the system, such as the processing instrument 30and a first tag reading device, which may comprise the handheld barcodescanner 42 and/or an instrument-mounted scanner bay 44, are connectedvia a laboratory information system (LIS) or other wired or wirelessnetwork represented by reference number 54 in FIG. 4 to data processingassets such as a first data processor element 50 and a second dataprocessor element 52. The processor elements 50 and 52 may comprisedifferent parts of a common processor, e.g., a computer, or differentelements of a common data processing algorithm that is executed by theprocessing assets of the system.

In general, aspects of the disclosure are implemented via control andcomputing hardware components, user-created software, data inputcomponents, arid data output components. Hardware components, e.g.,processor elements 50, 52, include computing and control modules (e.g.,system controller(s)), such as microprocessors and computers, configuredto effect computational and/or control steps by receiving one or moreinput values, executing one or more algorithm steps stored onnon-transitory machine-readable media (e.g., software) that provideinstruction for manipulating or otherwise acting on the input values,and output one or more output values. Such outputs may be displayed orotherwise indicated to a user for providing information to the user, forexample information as to the status of the instalment or a processbeing performed thereby, or such outputs may comprise inputs to otherprocesses and/or control algorithms. Data input components compriseelements by which data is input for use by the control and computinghardware components. Such data inputs may comprise positions sensors,motor encoders, as well as manual input elements, such as graphic userinterfaces, keyboards, touch screens, microphones, switches,manually-operated scanners, voice-activated input, etc. Data outputcomponents may comprise hard drives or other storage media, graphic userinterfaces, monitors, printers, indicator lights, or audible signalelements (e.g., buzzer, horn, bell, etc.).

Software comprises instructions stored on non-transitorycomputer-readable media which, when executed by the control andcomputing hardware, cause the control and computing hardware to performone or more automated or semi-automated processes.

In a typical implementation, before the cartridge 10 is placed into theprocessing instrument 30, the first machine-readable information tag 18is read by the first tag reading device, e.g., barcode reader 42 or 44,and the machine-readable sample identification tag 22 is also read bythe first tag reading device, e.g. handheld barcode reader 42 or 44.Data scanned from the machine-readable tags 18 and 22 is communicateddirectly or indirectly by the network 54 to the first data processorelement 50. First data processor element 50 is configured, e.g.programmed, to associate information read by the tag reading device 42from the first machine-readable information tag 18 with information readby the tag reading device 42 from the machine-readable sampleidentification tag 22. This will create an association betweeninformation uniquely identifying the cartridge 10 that is encoded in thefirst machine-readable information tag 18 with information uniquelyidentifying the sample (e.g., patient accession number) that is encodedin the machine readable sample identification tag 22.

In one embodiment, the instrument 30 will instruct the user to enteridentifying information for a particular bay 40 a-40 f into which thecartridge is to be inserted after sample has been added to thecartridge. Thus, the information scanned from the first machine-readableinformation tag 18 and the machine-readable sample identification tag 22becomes associated with the particular processing bay, e.g., 40 a.

Cartridge 10 is then placed into the processing instrument 30, forexample, into processing bay 40 a. After the cartridge 10 is placed intothe instalment 30, a second tag reading device operatively associatedwith the processing instalment and indicated by box 46 in FIG 4 isconfigured to read the second machine-readable information tag 20.Second tag reading device 46 may comprise an optical tag scanner, e.g.,a bar code scanner, or an electronic tag reading device (scanner)—whichmay be configured to scan by wireless or contactless transmission or byelectrical contact with some portion of the second machine readableinformation tag 20. Data read by the second tag reading device 46 iscommunicated via the network 54 to the second data processor element 52,which is configured, e.g., programmed, to compare the information readby the second tag reading device 46 from the second machine-readableinformation tag 20 with the information read by the first tag readingdevice 42 from the first machine readable information tag 18 to ensurethat the cartridge identifying information encoded into the firstmachine-readable information tag 18 corresponds to the cartridgeidentifying information encoded into the second machine-readableinformation tag 20.

In one embodiment, where the cartridge identifying information encodedinto the first and second machine-readable information tags 18 and 20comprises identical serial numbers, the second data processor 52confirms that the information read from the first and secondmachine-readable information tags is identical. In another embodiment,where the information encoded into the first and second machine-readableinformation tags is not identical but is associated with each other in arelational data base, the second data processor element 52 will beconfigured to do a table look-up to confirm that the cartridgeidentifying information read from the second machine-readableinformation tag 20 is properly associated with the cartridge identifyinginformation that was read from the first machine-readable informationtag 18.

FIG. 5 is a flow chart illustrating a redundant identification process70 using a sample processing device, such as sample cartridge 10, and asample processing instrument that receives the device, such asinstalment 30.

In a first step 72, sample is placed into the sample compartment 14 ofthe sample processing cartridge 10, and then the compartment is sealed,e.g., by closing a cap over a sample well.

In step 74, a machine-readable sample identification tag 22 is placed onthe sample processing cartridge 10. The machine-readable sampleidentification tag 22 may be an adhesively-backed label that is providedwith the sample material to be applied to the cartridge at the time thatsample material is placed in the sample compartment 14 and may include apatient accession number or other sample-identifying information. Inanother embodiment, the machine-readable sample identification tag maycomprises a tag, such as a bar code, an RFID chip, or a EEPROM chip,that is pre-applied to the sample processing cartridge, e.g., by themanufacturer, and which is encoded with a code that is unique to thatsample processing cartridge. The user then scans the pre-appliedmachine-readable sample identification tag to enter the unique code intothe instrument control system and then enters sample identificationinformation to associate the sample identification information with theunique code.

In steps 76 and 78, the user scans the machine-readable sampleidentification 22 and the first machine-readable information tag 18 withthe first tag reading device 42 (the order of steps 76 and 78 may bereversed). In step 80, the first data processor element 50 creates anassociation between the sample identification information scanned fromthe sample identification tag 22 and the cartridge identificationinformation scanned from the first machine-readable information tag 18.

In step 82, the cartridge 10 is inserted into a sample processing bay 40a-40 f of the sample processing instrument 30.

In step 84, with the cartridge 10 disposed within the sample processinginstrument 30, the second tag reading device 46 reads the secondmachine-readable information tag 20. Step 84 may be triggered by aswitch that is tripped when the cartridge is inserted into the sampleprocessing instrument 30.

In step 86, the second data processor element 52 compares theinformation scanned by the second tag reading device 46 front the secondmachine-readable information tag 20 with the information scanned by thefirst tag reading device 42/44 from the first machine-readableinformation tag 18. In step 88, the second data processor element 52determine whether the identifying information scanned from the secondmachine-readable information tag 20 properly corresponds to theidentifying information scanned from the first machine-readableinformation tag 18.

If the identifying information scanned from the second machine-readableinformation tag 20 does not properly correspond to the identifyinginformation scanned from the first machine-readable information tag 18,the cartridge 10 is rejected and the processing instrument 30 ceasesprocessing of the cartridge (step 90). A visual and/or audible warningsignal may be provided by the instrument 30, and the instrument mayinclude an eject feature for ejecting the cartridge from theinstrument—e.g., from the processing bay 40 a. If the identifyinginformation scanned from the second machine-readable information tag 20properly corresponds to the identifying information scanned from thefirst machine-readable information tag 18, the processing instrument 30continues operation, and test results may be associated with thesample-identifying information scanned by the fist tag-reading devicefrom the machine-readable sample identification tag 22 (step 92).

EXEMPLARY EMBODIMENTS

The following embodiments are encompassed by the foregoing disclosure.

Embodiment 1. A sample processing cartridge comprising:

-   -   a substrate configured to be inserted into a sample processing        instrument;    -   a sample compartment supported on said substrate and configured        to contain a fluid sample material;    -   one or more process compartments supported on said substrate and        configured to contain a process material, wherein said sample        compartment is connected or connectable to at least one process        compartment;    -   a first machine-readable information tag mounted on or embedded        in said substrate and encoded with cartridge-identifying        information and configured to be read by a device that is        external to a sample processing instrument; and    -   a second machine-readable information tag mounted on or embedded        in said substrate and encoded with cartridge-identifying        information corresponding to the cartridge-identifying        information encoded in said first machine-readable information        tag and configured to be read by a device within a sample        processing instrument.

Embodiment 2. The sample processing cartridge of embodiment 1, whereinsaid first machine-readable information tag comprises anoptically-readable tag.

Embodiment 3. The sample processing cartridge of embodiment 1 orembodiment 2, wherein said first machine-readable information tagcomprises a bar code.

Embodiment 4. The sample processing cartridge of any one of embodiments1 to 3, wherein said first machine readable information tag comprises a1-D or a 2-D bar code.

Embodiment 5. The sample processing cartridge of any one of embodiments1 to 4, wherein said second machine-readable information tag comprisesan electronically-readable tag.

Embodiment 6. The sample processing cartridge of any one of embodiments1 to 5, wherein said second machine-readable information tag comprises awirelessly-readable tag.

Embodiment 7. The sample processing cartridge of any one of embodiments1 to 5, wherein said second machine-readable information tag comprisesan RFID tag or an EEPROM tag.

Embodiment 8. The sample processing cartridge of any one of embodiments1 to 7, wherein the cartridge-identifying information encoded in saidsecond machine-readable information tag comprises information that isidentical to the cartridge-identifying information encoded in said firstmachine-readable information tag.

Embodiment 9. The sample processing cartridge of any one of embodiments1 to 8, wherein cartridge-identifying information comprises anidentification code comprised of a unique combination of numeric and/oralphabetic characters.

Embodiment 10. The sample processing cartridge of any one of embodiments1 to 9, further comprising a machine-readable sample identification tagencoded with sample-identifying information and configured to be read bya device that is external to a sample processing instrument.

Embodiment 11. A system for processing a sample comprising:

-   -   A. a sample processing cartridge comprising:    -   (1) a substrate;    -   (2) a sample compartment supported on said substrate and        configured to contain a fluid sample material;    -   (3) one or more process compartments supported on said substrate        and configured to contain a process material, wherein said        sample compartment is connected or connectable to at least one        process compartment;    -   (4) a first machine-readable information tag mounted on or        embedded in said substrate and encoded with        cartridge-identifying information and configured to be read by a        device that is external to a sample processing instrument; and    -   (5) a second machine-readable information tag mounted on or        embedded in said substrate and encoded with        cartridge-identifying information corresponding to the        cartridge-identifying information encoded in said first        machine-readable information tag;    -   B. a first tag reading device configured to read said first        machine-readable information tag and to read a machine-readable        sample identification tag placed on said cartridge;    -   C. a first data processor element configured to associate        information read from said first machine-readable information        tag by said first tag reading device with information read from        said machine-readable sample identification tag by said first        tag reading device;    -   D. a processing instrument configured to receive said sample        processing cartridge;    -   E. a second tag reading device operatively associated with the        processing instrument and configured to read said second        machine-readable information tag when a sample processing        cartridge is placed in the processing instrument; and    -   F. a second data processor element configured to compare the        information read from said second machine-readable information        tag by said second tag reading device with information read from        said first machine-readable information tag by said first tag        reading device to ensure the cartridge-identifying information        contained in said first machine-readable information tag        corresponds to the cartridge-identifying information contained        in said second machine-readable information tag.

Embodiment 12. The system of embodiment 11, wherein said second dataprocessing element is further configured to enable operation of saidprocessing instrument if the cartridge-identifying information containedin said first machine-readable information tag corresponds to thecartridge-identifying information contained in said secondmachine-readable information tag or disable operation of said processinginstrument if the cartridge-identifying information contained in saidfirst machine-readable information tag does not correspond to thecartridge-identifying information contained in said secondmachine-readable information tag.

Embodiment 13. The system of embodiment 11 or embodiment 12, whereinsaid first machine-readable information tag comprises anoptically-readable tag, and said first tag reading device comprises anoptical tag scanner.

Embodiment 14. The system of any one of embodiments 11 to 13, whereinsaid first machine-readable information tag comprises a bar code, andsaid first tag reading device comprises a hand-held bar-code scanner.

Embodiment 15. The system of any one of embodiments 11 to 14, whereinsaid first machine readable information tag comprises a 1-D or a 2-D barcode.

Embodiment 16. The system of any one of embodiments 11 to 15, whereinsaid second machine-readable information tag comprises anelectronically-readable tag, and said second tag reading devicecomprises an electronic tag reading device.

Embodiment 17. The system of any one of embodiments 11 to 16, whereinsaid second machine-readable information tag comprises awirelessly-readable tag, and said second tag reading device comprises awireless tag scanner.

Embodiment 18. The system of any one of embodiments 11 to 17, whereinsaid second machine-readable information tag comprises an RFID tag or anEEPROM tag.

Embodiment 19. The system of any one of embodiments 11 to 18, whereinthe cartridge-identifying information encoded in said secondmachine-readable information tag comprises information that is identicalto the cartridge-identifying information encoded in said firstmachine-readable information tag.

Embodiment 20. The system of any one of embodiments 11 to 19, whereincartridge-identifying information comprises an identification codecomprised of a unique combination of numeric and/or alphabeticcharacters

While the subject matter of this disclosure has been described and shownin considerable detail with reference to certain illustrativeembodiments, including various combinations and sub-combinations offeatures, those skilled in the an will readily appreciate otherembodiments and variations and modifications thereof as encompassedwithin the scope of the present invention. Moreover, the descriptions ofsuch embodiments, combinations, and sub-combinations is not intended toconvey that the inventions requites features or combinations of featuresother than those expressly recited in the claims. Accordingly, the scopeof this disclosure is intended to include all modifications andvariations encompassed within the spirit and scope of the followingappended claims.

1-20. (canceled)
 21. A method for processing a patient sample, themethod comprising: performing the following in a processing instrument:(a) receiving a cartridge in the processing instrument, wherein thecartridge comprises a first machine-readable cartridge identificationtag, a second machine-readable cartridge identification tag, and amachine-readable sample identification tag; (b) creating an associationbetween sample identification information scanned from themachine-readable sample identification tag prior to the cartridge beingreceived in the processing instrument and cartridge identificationinformation scanned from the first machine-readable cartridgeidentification tag prior to the cartridge being received in theprocessing instrument; (c) scanning the second machine-readablecartridge identification tag; (d) determining whether there is a matchbetween the cartridge identification information scanned from the firstmachine-readable cartridge identification tag and cartridgeidentification information scanned from the second machine-readablecartridge identification tag; and (e) in response to determining thatthere is not a match, discontinuing processing of the cartridge.
 22. Themethod of claim 21, wherein the cartridge is ejected from the processinginstrument to discontinue the processing of the cartridge.
 23. Themethod of claim 21, further comprising providing a visual and/or anaudible warning in response to determining that there is not a match.24. The method of claim 21, wherein the machine-readable sampleidentification tag and the first machine-readable cartridgeidentification tag are scanned by a first tag reading device.
 25. Themethod of claim 24, wherein the second machine-readable cartridgeidentification tag is scanned by a second tag reading device.
 26. Themethod of claim 21, wherein a first data processor creates theassociation.
 27. The method of claim 26, wherein a second data processordetermines whether there is a match.
 28. The method of claim 21, furthercomprising: (f) in response to determining that there is a match,continue processing of the cartridge.
 29. The method of claim 21,further comprising: (f) in response to determining that there is amatch, associating test results with the sample-identifying informationscanned from the machine-readable sample identification tag.
 30. Themethod of claim 21, wherein the second machine-readable identificationtag comprises an electronically-readable tag or chip or anoptically-readable tag.
 31. The method of claim 21, wherein themachine-readable sample identification tag: (i) is an adhesively-backedlabel that is provided with the patient sample to be applied to thecartridge at a time that the patient sample is loaded in the cartridge;or (ii) is a bar code, an RFID chip, or a EEPROM chip that ispre-applied to the cartridge.
 32. The method of claim 31, wherein themachine-readable sample identification tag is scanned by a barcodereader, an RFID reader, or a EEPROM reader.
 33. The method of claim 21,further comprising associating a test result with the cartridgeidentification information scanned from the first machine-readablecartridge identification tag, the cartridge identification informationscanned from the second machine-readable cartridge identification tag,the sample identification information scanned from the machine-readablesample identification tag, or combinations thereof.
 34. A method forprocessing a patient sample, the method comprising: performing thefollowing in a processing instrument: (a) receiving a cartridge in theprocessing instrument, wherein the cartridge comprises a firstmachine-readable cartridge identification tag, a second machine-readablecartridge identification tag, and a machine-readable sampleidentification tag; (b) scanning the second machine-readable cartridgeidentification tag; (c) comparing encoded information scanned from thefirst machine-readable cartridge identification tag prior to thecartridge being received in the processing instrument with encodedinformation scanned from the second machine-readable cartridgeidentification tag; (d) processing the sample; (e) generating a testresult; and (f) creating an association between the test result andsample identification information scanned from the machine-readablesample identification tag prior to the cartridge being received in theprocessing instrument.
 35. The method of claim 34, wherein theinformation encoded in the first machine-readable cartridgeidentification tag corresponds to the information encoded in the secondmachine-readable cartridge identification tag.
 36. The method of claim34, wherein the second machine-readable cartridge identification tag isnot configured to be read outside the processing instrument.
 37. Amethod for processing a patient sample, the method comprising:performing the following in a processing instrument: (a) receiving acartridge in the processing instrument, wherein the cartridge comprisesa first machine-readable cartridge identification tag, a secondmachine-readable cartridge identification tag, and a machine-readablesample identification tag; (b) scanning the second machine-readablecartridge identification tag; (c) comparing cartridge identificationinformation scanned from the first machine-readable cartridgeidentification tag prior to the cartridge being received in theprocessing instrument with cartridge identification information scannedfrom the second machine-readable cartridge identification tag; and (d)providing a visual and/or an audible warning in response to a mismatchbetween the cartridge identification information scanned from the firstmachine-readable cartridge identification tag and the cartridgeidentification information scanned from the second machine-readablecartridge identification tag.
 38. The method of claim 37, furthercomprising: (e) ejecting the cartridge from the processing instrument todiscontinue processing of the cartridge in response to a mismatchbetween the cartridge identification information scanned from the firstmachine-readable cartridge identification tag and the cartridgeidentification information scanned from the second machine-readablecartridge identification tag.
 39. The method of claim 38, furthercomprising creating an association between the sample identificationinformation scanned from the machine-readable sample identification tagand the cartridge identification information scanned from the firstmachine-readable cartridge identification tag.
 40. The method of claim37, wherein the first machine-readable cartridge identification tag isscanned by a first tag reading device external to the processinginstrument, and wherein the second machine-readable cartridgeidentification tag is scanned by a second tag reading device internal tothe processing instrument.